Table 1

Emerging issues in paediatric research consent forms
Emerging issues in paediatric research discussed in consent forms N total (43) %
1. Consent
Scope of parental consent
Specific 13 30
Broad 18 42
Broad or Specific (option) 2 5
Not addressed 10 23
Child’s ability to dissent
Addressed 19 44
Not addressed 24 56
Possibility for child’s assent and/or future consent
Assent or future consent addressed 22 51
Neither addressed 21 49
2. Risks and benefits
Financial, social or psychological issues as potential risks 11 26
Cumulative harms considered 3 7
How ‘benefit’ characterised
Indirect 29 67
Unspecified 11 26
Direct or combination of direct/indirect 3 7
3. Extent of withdrawal
Ability for child to withdraw
Addressed 28 65
Not addressed 15 35
Extent of withdrawal
All data/samples destroyed 7 16
No further use of data/samples 1 2
Retention of data/samples collected to date 3 7
Not addressed or unspecified 32 74
Process for handling parental-child disagreement on withdrawal 0 0
4. Return of research results and incidental findings
Not addressed 17 40
Addressed 26 60
No return 6 14
General/aggregate results return 7 16
Individual results return 7 16
General/aggregate and individual results return 6 14
Any return of results that include incidental findings (with or without option) 8 19
5. Privacy and confidentiality
Scope of parental right to access information concerning their child 0 0
Nomenclature for data/sample identifiability
Unspecified 14 33
Coded 25 58
Anonymised 4 9
6. Transfer and data sharing
Retention period(s) of data/samples
Indefinite 12 28
Specified time periods 18 42
Combination of indefinite and specified time periods, depending on whether material is data or samples 4 9
Not addressed 9 21
Access to data/samples
No transfer 2 5
Disclosure that data/samples may be transferred to another location 17 40
Disclosure and discussion of procedure for external data/sample transfer 4 9
Not addressed 20 47

Dove et al.

Dove et al. BMC Medical Ethics 2013 14:5   doi:10.1186/1472-6939-14-5

Open Data